FDA recall D-0645-2016

Product

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Reason for recall

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

Distribution

U.S. Nationwide including Puerto Rico.

Key facts

Status

Terminated

Initiation date

2016-01-18

Report date

2016-02-03

Termination date

2020-01-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tampa, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2016